| ObjectiveGreat difference in the quality of traditional Chinese medicine raw materials is one of the important factors result in quality difference of Chinese patent medicine.Therefore,controlling the quality uniformity of raw materirals before application in production could be very helpful to improve the quality uniformity of traditional Chinese medicine.Based on previous project Research on the Quality Uniformity Control Technology in the Production of Proprietary Chinese Medicine Feeding Yinpian(Project number:201307009),the objective of this project is to investigate the quality uniformity of raw materials in prescription,establish an effective method for multi-marker components quality uniformity control of pre-application decoction pieces,and compile an application software for multi-marker components uniformity calculation.According to previous research results,this study will select twenty kinds of decoction pieces and three kinds of Chinese herbal compounds as pattern drugs,combine dose-effect relationship method to study the evaluation standard for quality uniformity of traditional Chinese medicine,apply process integration fingerprinting(PIF)to research quality uniformity control method for traditional Chinese medicine fingerprint component,develop an intelligent analysis system software which could deal with PIF fingerprint component to control quality uniformity of traditional Chinese medicine,establish control strategy and operation procedure for controlling quality uniformity of traditional Chinese medicine,which will be validated and applied in practical production of traditional Chinese medicine.Method and ResultTo establish the Compound Danshen tablets,tiger force Bulk tablets,king wear anti-inflammatory capsule and forefront shule capsule quality homogeneity detection method;Establish variable importance projection analysis in salvia miltiorrhiza compound danshen film the research method of the relationship between the quality and efficacy of traditional Chinese medicine quality of homogenization,the necessity to provide effective argument homogenization reference standard for the quality of traditional Chinese medicine(TCM)provides pharmacodynamics research methods.Development of Chinese medicine yinpian production input fingerprint and the composition of homogenization analysis software system,intelligent and in model medicine yinpian homogenization feeding application in practical production.1?The Study on The Method of Model Drug Testing(1)Effect was established by using HPLC method,danshen medicinal herbs and notoginseng medicinal materials and finished products of phenolic acid B and tanshinone type IIA,Dan ginseng saponin Rg1 and ginseng saponin Rb1,panax notoginseng saponins R1 content detection method,the result is accurate and reliable detection approach,it can be used as a quality uniformity effect evaluation test;(2)The HPLC method is adopted to establish the tiger force scattered pieces of grass and notoginseng medicinal materials and finished products of benzoyl monkshood alkali,benzoyl hypaconine and benzoyl mesaconine and ginsenosides Rgl,ginsenosides Rb1,ginsenosides content of notoginseng saponin R1 detection method,the result is accurate and reliable detection approach,it can be used as a tiger force quality homogeneity evaluation test;(3)Established by HPLC method in anti-inflammatory capsule of andrographolide medicinal materials and the elder brother of the king medicinal materials and finished product new paniculta lactone,dehydration paniculta lactone and west daphnetin content detection method,the HPLC method is adopted to establish the creat medicinal materials and the elder brother of the king medicinal materials and finished products fingerprint detection methods,the result is accurate and reliable detection approach,as king wear anti-inflammatory capsule quality homogeneity evaluation testing;(4)The HPLC method is adopted to establish the forefront shule capsule epimedium herbs and huangqi herbs and finished product to our herb C,epimedium glycoside,astragalus glycosides,calycosin separately content detection method and HPLC method is adopted to establish the epimedium herbs and astragalus membranaceus medicinal materials and finished product fingerprint detection methods,the result is accurate and reliable detection approach,it can be used as a front shule capsule quality homogeneity evaluation testing;2?DPVPH Method in Salvia Miltiorrhiza Compound Danshen Preparations Quality Differences Affect Efficacy Research(1)Through the medicated serum in vitro anoxia/reoxygenation CMEC danshen medicinal materials quality differences in study of compound salvia miltiorrhiza and influence of danshen medicinal dosage of efficacy and DPVPH and Hill equation method is used to analyze relationship between quality and efficacy of compound salvia miltiorrhiza in salvia miltiorrhiza and index component content threshold,as a result,the quality of danshen medicinal materials of differences of compound salvia miltiorrhiza finished in vitro anoxia/reoxygenation affects obviously the efficacy of CMEC,with the increase of dosage and of danshen medicinal materials quality,hypoxia/reoxygenation in vitro cell vitality of CMEC showed a trend of increase,NO and ET showed a trend of decrease;DPVPH method analysis,Dan phenolic acid B affects the biggest effectiveness index is SOD,tanshinone most affected is NO efficacy index;Hill equation analysis method,the compound danshen film Dan phenolic acid B ED50=13.15 mg/tablet,[ED]20?[ED]80= 9.85?18.93 mg/80 slices,calculated Dan phenolic acids in danshen medicinal B content is:44.65 mg/g,the scope of content deviation:33.45?64.28 mg/g,deviation control of-25%?+43.9%;Compound danshen film tanshinone ?AED50= 0.88 mg/tablet,[ED]20?[ED]80=0.76?0.99 mg/piece,tanshinone type ?A content in danshen medicinal materials as follows:8.89 mg/g,content deviation range is:7.64?9.96 mg/g,deviation control for-13.6%?+12.5%.(2)Through study of compound salvia miltiorrhiza in blood stasis rats model of danshen medicinal materials quality differences and danshen medicinal dosage on hemorheology in blood stasis rats model and pharmacodynamics index detection,and DPVPH and Hill equation method is used to analyze relationship between quality and efficacy of compound salvia miltiorrhiza in salvia miltiorrhiza and index component content threshold,as a result,the quality difference of danshen medicinal materials of compound salvia miltiorrhiza finished in rats had a great effect on the efficacy of vascular endothelial cells in the body,with the increase of danshen medicinal materials quality and amount,each effectiveness indexes have significant improvement trend;DPVPH analysis showed that the greatest pharmacodynamic index that affect salvianolic acid B was 60S-1,and the maximal pharmacodynamic index of tanshinone was the number of circulating endothelial cells.Hill analysis showed that ED50 of salvianolic acid B in Compound Danshen Tablets was 10 mg per tablet.[ED]20?[ED]80 was 8.82 to 16.58 mg per tablet.we can deduce the content of salvianolic acid B in salvia miltiorrhiza was 35.18 mg/g,and the deviation range was 29.95 to 56.30 mg/g,the deviation is controlled to-0.60%?+15%,ED50 of the tanshinone IIA in Compound Danshen Tablets was 0.77 mg per tablet.And[ED]20?[ED]80 was 0.56 to 0.86mg per tablet.The content of tanshinone IIA in Salvia miltiorrhiza was 7.75mg/g,the deviation range is 5.64 to 8.66 mg/g,and the deviation is controlled to-27.2%?+ 11.7%.3?According to the requirements of the production feeding of Chinese medicinal decoction pieces and the characteristics of the process,a set of homogenization intelligent analysis software system for the decoction pieces feeding is compiled.The software includes a fingerprint superimposed display module,a fused fingerprint generation and display module,a mean fingerprint pattern generation and display module,a fingerprint Similarity analysis module,fingerprint analysis component peak analysis module and intelligent parallel blending optimization module.Through software programming,the function of each module has been realized,and a set of intelligent analysis software for the production of Chinese medicine decoction pieces has been successfully developed.4?The intelligent analysis software developed in the study was applied to the actual production of model drugs.As a result:(1)On the compound Danshen tablets of salvia miltiorrhiza and Panax Notoginseng homogenized feeding,the difference of RSD between salvianolic acid B,tanshinone IIA,ginsenoside Rgl,ginsenoside Rbl and notoginseng saponin R1 was less than 7%.While the RSD value of the product was not more than 10%,the highest reached 34.87%;(2)On the compound Tiger force piece of Radix Aconiti Kusnezoffii and Panax Notoginseng homogenized feeding,the difference of RSD between the content of benzoyl aconitine,benzoyl aconitine and benzoyl neostearine was less than 3%.While the RSD value of the non-homogeneous product content was not more than 9%,the highest reached 11.43%;(3)On the compound Chuan wang xiao yan Capsule of Andrographis paniculata and Wikstroemia indica homogenized feeding,the RSD of the content of new andrographolide was 6.80%,the RSD of dehydration andrographolide was 6.78%,the RSD of the daphnoretin was 5.12%,and the homogeneity was much higher than that of the commercial varieties(the RSD of the new andrographolide was 20.01%,The RSD of dehydration andrographolide was 25.12%,and the RSD of the daphnoretin was 40.58%).At the same time,the similarity of fingerprints of finished products was above 0.985,and the similarity of commercially available productsranged from 0.792 to 0.937.(4)On the compound Qainlieshule Capsule of epimedium and astragalus homogenized feeding,The RSD of the content of Epidemin C,icariin,astragaloside,calycosin in finished product was 6.84%,2.20%,4.59%and 8.81%,respectively,while the RSD of the content of the non-homogeneous marketed products was34.02%,23.88%,10.80%and 16.51%,respectively.In addition,the similarity of the fingerprints of commercially available Qainlieshule Capsule was was between 0.880 and 0.963,and the similarity of homogenization products ranged from 0.962 to 0.992,the similarity is greatly improved,which indicates that the consistency of product quality is improved obviously after homogenization.conclusion:The application of in vivo and in vivo pharmacological experiments showed that the quality difference of medicinal materials had a significant effect on the quality and efficacy of the finished product,and the application method of variable importance projection analysis in the dose-effect relationship of traditional Chinese medicine was established.The method could be scientifically analyzed Indicators of traditional Chinese medicine composition corresponding to multiple efficacy,the corresponding components of the most relevant and important indicators of efficacy;in addition,The ED50,ED20,and ED80 of Salvia miltiorrhiza in the compound Salvia miltiorrhiza were calculated by using the HILL equation,Which provides a reference method for the study of dose-effect relationship for homogeneous reference standard of traditional Chinese medicine.This paper established the Chinese medicine Pieces production and feeding uniformity intelligent analysis software system,which is based on the analysis of fingerprints of traditional Chinese medicine,the uniformity of index components and the distribution of fingerprints,and can be applied in the practice of traditional Chinese medicine production operating. |
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